Home NDC 64980-598-01 Doxepin hydrochloride
Product NDC 64980-598
Requested package NDC 64980-598-01
11-digit product format 649800598
Labeler code 64980
Product ID 64980-598_2877d1f2-a036-4577-926d-b09828350ea1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA217975
Marketing category ANDA
Marketing start 2023-12-25
Substance DOXEPIN HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217975-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 A217975-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 A217975-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 A217975-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 A217975-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 110 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217975-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217975-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2023-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217975-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2023-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217975-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217975-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2023-08-21 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 110 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Doxepin hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3U9A0FE9N5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000048 Internal RxNorm lookup 1000058 Internal RxNorm lookup 1000070 Internal RxNorm lookup 1000076 Internal RxNorm lookup 1000097 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-598-01 Doxepin hydrochloride 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-598 DOXEPIN HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 1 package rows 20250502_66c6af99-9909-4b18-a43b-898a1c4a34d7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-598-01 64980059801 100 CAPSULE in 1 BOTTLE (64980-598-01) 100 capsule 2023-12-25 No No Current